Site Contracts & Budgets Specialist

Lexitas•Durham, NC

About The Position

Support the negotiation and execution of clinical trial site agreements and budgets for awarded studies in accordance with Lexitas SOPs and procedures.

Requirements

Bachelor-level degree along with one year of contracting experience or an equivalent combination of education and experience, including demonstrable experience acting as a contract negotiator.
An Associate-level degree with three years of contracting experience, or an equivalent combination of education and experience, including demonstrable experience acting as a contract negotiator.
Advanced English level
Strong negotiating and communication skills.
Strong organizational and planning skills.
Strong interpersonal skills and a team player.
Understanding of regulated clinical trial environment and knowledge of drug development process.
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
Solid understanding of clinical trial contract management.

Nice To Haves

Experience working with or at research sites perferred

Responsibilities

Negotiate site Clinical Study Agreements (CSAs) and budget templates based upon study parameters
Develop investigator grant estimates and proposal text to support the proposal development process.
Draft and negotiate Confidential Disclosure Agreements (CDAs)
Utilize and maintain contract and budget templates and contracting systems, tools, processes, and training materials for selected studies according to the Scope of Work and Project Plan, within the agreed project strategy.
Ensure collaboration, including communication with sponsors, partners, and stakeholders to successfully deliver the agreed project scope in compliance with sponsor requirements and/or Project Management Plan
Provide specialist operational and financial contracting support to facilitate efficient business development and initiation and maintenance of clinical trials, while enabling compliance with regulatory requirements.
Ensure overall contracting efficiency and adherence to project timelines and financial goals; report contracting performance metrics and out of scope contracting activities as required.
Ensure accurate completion and maintenance of internal systems (CTMS), databases, tracking tools, timelines and project plan
Engage in learning updated contracting processes and procedures to facilitate faster and more accurate contract negotiation, including acceptance of guidance and critiques to facilitate such learning
Ensure timely completion of trainings required for this position